EU approves Darzalex subcutaneous formulation for multiple myeloma.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted marketing authorisation for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma. Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation. In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available. The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.

Data supporting the approval show that daratumumab SC demonstrated a consistent overall response rate (ORR) and a similar safety profile compared with daratumumab IV in patients with relapsed or refractory MM. In addition, there was a nearly two-thirds reduction in systemic infusion-related reactions (IRRs) for daratumumab SC compared to daratumumab IV (13 percent vs. 35 percent, respectively). The novel SC formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20).

The approval is supported by data from the Phase II PLEIADES (MMY2040) and Phase III COLUMBA (MMY3012) studies. In the PLEIADES study, which evaluated the efficacy and safety of daratumumab SC in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan, and prednisone in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone in relapsed or refractory patients who received one prior line of therapy. In the COLUMBA study, at a median follow-up of 7.5 months, the ORR was 41 percent for patients taking daratumumab SC as a monotherapy, compared to 37 percent for those taking daratumumab IV as a monotherapy. The ORR was similar across all clinically relevant subgroups, including bodyweight. The ratio of geometric means of Ctrough for daratumumab SC over daratumumab IV was 108 percent. The progression-free survival was comparable between the daratumumab SC and daratumumab IV. The median duration for each SC injection was five minutes, compared to more than three hours with IV infusions. The most common Grade 3/4 treatment-emergent adverse events were thrombocytopenia (14 percent vs. 14 percent), anaemia (13 percent vs. 14 percent) and neutropenia (13 percent vs. 8 percent).